Dimensionless quantities in the evaluation of novel composite disintegrants

Composites of native tapioca starch and mannitol were prepared by co-fusion and co-grinding to produce novel excipients. The disintegrant activity of the novel excipients was evaluated using the disintegration efficiency ratio (DER) in a paracetamol tablet formulation with native tapioca starch as control. Two dimensionless quantities DERN and DERC were then used to assess the efficiency of the novel excipients in enhancing the quality of the paracetamol tablets. The results indicated that the novel excipients would enhance the balance between the mechanical and disintegration properties of tablets as reflected in the DER values. The results suggested that a particular combination of process and formulation variables is required for the optimum activity of the novel disintegrants. The study concluded that the activity of the novel excipients was dependent on the mode of incorporation, compression load and method of compositing.